Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed on the Nutritional Status, Gut Microbiota and Quality of Life of Children With Acute Lymphocytic Leukemia: an Egyptian Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Study Parameters
研究概览
简要总结
This is a randomised, controlled, open-label intervention study. It is hypothesized that supplementation with a fibre enriched sip feed will improve the nutritional status, gut microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may enhance their immune response. This could give them a better chance to finish their induction chemotherapy successfully with fewer side effects.
详细描述
Study objectives:
Primary objective:
To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the nutritional status of Egyptian children with acute lymphocytic leukemia (ALL) compared to standard dietary counseling.
Secondary objective:
To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the gut microbiota and quality of life (QoL) of Egyptian children with ALL compared to standard dietary counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed male and female paediatric ALL patients presenting in the study period.
- •Age should be above 2 years and children should be pre-pubertal.
- •Hospitalized for the entire (6 week) intervention period.
- •About to receive? induction chemotherapy.
- •Able to tolerate oral feeding.
- •Written informed consent from parents/guardian (and child, if applicable to local law).
排除标准
- •ALL patients < 2 years and those who show signs of puberty.
- •ALL patients who cannot tolerate oral feeding and/or are on parenteral nutrition.
- •ALL patients with a known history of cow's milk allergy/intolerance or galactosemia.
- •ALL patients requiring a fibre-free diet.
- •Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements.
- •Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
结局指标
主要结局
Study Parameters
时间窗: 42 days
Primary * Change in body weight between Baseline and Day 42 \[kg, weight-for-age z score, weight-for-height z-score\] * Percentage of children with body weight loss between Baseline and Day 42 \[%\]
次要结局
- Study Parameters(from day 1 to day 91 of the study)